About This Role

At Biogen Digital Health (BDH), we aspire to transform Biogen and patients’ lives by making personalized & digital medicine in neuroscience a reality. Powered by data-science and digital technologies, we drive solutions to advance research, clinical care, and patient empowerment. Our team strives for real impact through excellence, innovation, and collaboration.

In this individual contributor role, you will serve as BDH’s Regulatory point of contact for Software as a Medical Device and digital healthcare tool development, clinical evaluation, and commercialization. Reporting to the Head, BDH SaMD Regulatory and Quality, you will provide subject matter expertise on global SaMD Regulatory requirements, define regulatory strategies for key markets, operationalize strategies in BDH’s Quality Management System, and perform regulatory due diligence with key suppliers.

What You’ll Do

• Create a regulatory strategy for assessing, planning and adopting SaMD, mobile applications, and digital tools into clinical studies, both investigational and commercial
• Develop processes, SOPs/Work Instructions, Forms, tools, and or repositories to standardize and formalize the SaMD regulatory strategy
• Serve as regulatory representative on BDH project teams, creating or evaluating and approving project deliverables, and assessing impact of proposed SaMD product changes
• Define and perform regulatory due diligence for potential vendors and partners
• Support development of required regulatory filings/notifications/submissions for investigational and commercial SaMD products
• Oversee regulatory consultants, monitor budget expenditures and Statements of Work
• Support internal, external, and regulatory body audits as needed
• Prepare and deliver informal and formal presentations to diverse internal audiences, distilling regulatory expertise into actionable information
• Demonstrate strong organizational skills, and ability to support multiple workstreams in support of project timelines and BDH goals
• Exhibit strong interpersonal skills and the ability to deal effectively with a variety of personnel within BDH and across Biogen; able to distill subject matter expertise for a variety of functions

Who You Are

A regulatory subject matter expert with in-depth medical device knowledge across multiple global regions, able to effectively collaborate with various functional groups, and to communicate regulatory requirements. Significant experience with SaMD or highly automated (SiMD) medical devices in multiple markets; South America and/or Pacific Asian market experience is ideal.

Awareness of applicable legislation, regulations, guidance, and standards, understands application of cGMP for Medical Devices and Software as a Medical Device specifically. Exceptional technical and influential writing ability, with strong capabilities to synthesize and analyze disparate information.

Required Skills

• Bachelor’s degree
• 5+ years of medical device Regulatory Affairs experience
• 2+ years of SaMD or automated (SiMD) medical device Regulatory experience
• Strong communication and collaboration capabilities

Preferred Skills

• Bachelor’s degree focus in Life/Health Sciences or Engineering
• 4+ years SaMD or SiMD Regulatory experience
• Clinical study (GCP) awareness
• Regulatory Affairs-specific certification/qualifications/training

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Why Biogen Digital Health?

You will join an international, diverse team of 100+ talented humans who are passionate about making our vision a reality. Our team at Biogen Digital Health rejects the status quo and lives by agile principles. You’ll work directly with an outstanding team of neuroscientists, clinicians, data scientists, biostatisticians, digital product managers, user experience designers, and engineers that work across disciplines to make a lasting impact for patients.